NCT02231658终止1 期
Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Change from baseline (week -1) in the number of reflux episodes
研究概览
简要总结
The present study will compare lixisenatide and liraglutide in a population of subjects with T2DM not optimally controlled on OADs and / or insulin, which is the target population for these medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •Male or female aged 18-65 years (both inclusive)
- •T2DM diagnosis
排除标准
- •Contraindications (including known or suspected hypersensitivity) to GLP-1 mimetics
- •Use of GLP-1 mimetics or DPP-IV inhibitors
- •Clinically relevant dysglycaemia as indicated by HbA1C ≥ 10%
研究组 & 干预措施
Liraglutide
Experimental
The highest injected once daily dose will be 1.8 mg s.c. for liraglutide.
干预措施: Liraglutide (Drug)
Lixisenatide
Experimental
The highest injected once daily dose will be 20µg s.c. for lixisenatide.
干预措施: Lixisenatide (Drug)
结局指标
主要结局
Change from baseline (week -1) in the number of reflux episodes
时间窗: 24 hours after 10 weeks of treatment
次要结局
- Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus(After 10 weeks of treatment)
研究者
研究点 (2)
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